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U.S. Department of Health and Human Services

Class 2 Device Recall Mammo Test

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  Class 2 Device Recall Mammo Test see related information
Date Initiated by Firm January 21, 2009
Date Posted June 01, 2009
Recall Status1 Terminated 3 on June 01, 2009
Recall Number Z-1318-2009
Recall Event ID 51449
510(K)Number K042095  
Product Classification x-ray guided stereotactic biopsy system - Product Code JAQ
Product Mammo Test Model number 10144185, x-ray guided stereotactic biopsy system
Code Information Serial numbers 10102, 10103, 10105, and 10106
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Michael Van Ryn
610-219-6300
Manufacturer Reason
for Recall		 Table may unintentionally lift during procedure
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens Medical Solutions issued a Safety Advisory Notice dated 1/22/09 which informs the customers of the potential issues and recommends that they stop using their MammoTest System until the prone table has been repaired. Linear Medical visited the customers to repair the weld joint on the prone table by January 23, 2009.
Quantity in Commerce 4 units
Distribution USA distribution to IL, NY, SC, and WA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAQ and Original Applicant = FISCHER IMAGING CORP.
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